Immediate Effects of Ankle MWM and Taping on Gait and Balance in Stroke Patients

November 5, 2024 updated by: Ismail Okur, Kutahya Health Sciences University

Immediate Effects of Ankle Mobilization With Movement and Mulligan Talocrural Taping on Gait and Balance in Stroke Patients

Disorders caused by stroke may lead to significant limitations, especially in ankle range of motion, and may cause impairments in walking and balance functions. This limitation in ankle range of motion leads to difficulties in weight transfer, stability, and balance. As a result, there is a decrease in walking performance and an increased risk of falls. Various interventions have been used to improve ankle dorsiflexion passive range of motion, including gastrosoleus muscle stretching, muscle strengthening training, functional electrical stimulation training, proprioceptive control training, taping, manual therapy, different mobilization techniques, and ankle mobilization with motion (MWM).There are limited studies investigating the immediate effects of MWM and taping on gait and balance in stroke patients. This study was planned to investigate the effect of Mulligan's ankle MWM technique and talus stabilization taping on spatiotemporal gait and balance parameters in stroke patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Locations

  • Turkey
      • Kütahya, Turkey, 43100
        • Kutahya Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Having a unilateral stroke for more than three months,
  2. Being able to walk 10 meters without an assistive device,
  3. Being able to walk unassisted before having a stroke,
  4. Having a score of 3 or lower on the Modified Ashworth Scale (MAS),
  5. Be able to follow simple verbal instructions,
  6. Being Volunteer

Exclusion Criteria:

  1. Having had more than one stroke,
  2. Cerebellar involvement,
  3. Having severe visual impairment,
  4. Having cognitive impairment,
  5. Severe aphasia,
  6. Apraxia,
  7. Having contraindications for joint mobilization (e.g. ankle hypermobility, trauma, inflammation),
  8. Have significant lower limb problems such as fractures or arthritis,
  9. Having undergone musculoskeletal surgery less than 6 months ago,
  10. Having joint contracture in the paretic ankle that prevents walking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Movement with Motion technique of Mulligan Concept to the ankle joint and taping will be performed on the participants in the Intervention Group.
Other: Mobilisation with Movement and Taping
For MWM for the talocrural joint, the hemiparetic side of the participant is positioned in a standing position on a stool. A non-elastic belt is passed behind the patient's distal tibia and secured around the therapist's pelvis. The patient is asked to perform active knee flexion and ankle dorsiflexion with weight on the hemiparetic side. Meanwhile, the therapist performs forward sliding of the tibia with the help of the belt. For 10 seconds active and painless sliding takes place and then return to the starting position. This application is applied as 10 repetitions, 6 sets, and 1 minute rest between sets. Following the MWM application, Mulligan talus stabilization taping is performed. For this taping, the participants' ankles are placed on a stool at a height of 30 cm and their feet are placed in the dorsiflexion position. The therapist starts taping from the plantar surface of the calcaneus using rigid tape and will wrap and stabilize the talus.
Sham Comparator: Sham Group
Movement with Motion technique of Mulligan Concept to the ankle joint with lower amplitude and taping with minimal tension will be performed on the participants in the Sham Group.
Other: Sham
During joint mobilization with movement, the therapist will stabilize the ankle while performing knee flexion and ankle dorsiflexion by actively moving the center of mass to the affected side, but the shear force required to slide the tibia forward with the belt will not be given. Placebo taping following the application will be applied in such a way that there is no stabilization effect without tension between the same start and end points.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stride length
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device. Stride length spatiotemporal parameters of gait will be obtained from this platform. The date will recorded as a millimeter.
Pre-intervention/sham and immediately after the intervention/sham
Stride width
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device. Stride width spatiotemporal parameters of gait will be obtained from this platform. The date will recorded as a millimeter.
Pre-intervention/sham and immediately after the intervention/sham
Cadance
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device. Cadance spatiotemporal parameters of gait will be obtained from this platform. The date will recorded as the number of steps per minute.
Pre-intervention/sham and immediately after the intervention/sham
Walking speed
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device. Walking speed spatiotemporal parameters of gait will be obtained from this platform. The date will recorded as m/s.
Pre-intervention/sham and immediately after the intervention/sham
The symmetry of the center of pressure changes during walking
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device. The symmetry of the center of pressure changes during walking spatiotemporal parameters of gait will be obtained from this platform. The date will recorded as a millimeter.
Pre-intervention/sham and immediately after the intervention/sham
The maximum force on the feet during walking
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device. The maximum force on the feet during walking spatiotemporal parameters of gait will be obtained from this platform. The date will recorded as N/cm2.
Pre-intervention/sham and immediately after the intervention/sham
The distribution of pressure on the feet
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device. The distribution of pressure on the feet spatiotemporal parameters of gait will be obtained from this platform. The date will recorded as percentages.
Pre-intervention/sham and immediately after the intervention/sham
Balance
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
Zebris FDM-2 device will also be used for the evaluation of balance parameters. Participants will be asked to stand on the device for 60 seconds without shoes, arms at their sides, eyes open and looking at a point 3 meters away. As a result of the evaluation, changes in the center of pressure will be recorded.
Pre-intervention/sham and immediately after the intervention/sham

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
10-meter walk test
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
The 10-meter walk test will be used to assess the walking speed of stroke patients. Patients will be asked to walk a 10-meter track. Walking times will be recorded in seconds.
Pre-intervention/sham and immediately after the intervention/sham
Timed up and go test
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
The timed get up and walk test will be used to measure the dynamic balance of individuals. It includes the measurement of the time it takes for the participant to get up from the chair, walk 3 meters at their own pace, turn around, return to the chair and sit back in the chair.
Pre-intervention/sham and immediately after the intervention/sham

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: İsmail Okur, Dr., Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KHSU-2023/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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